Articles

Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.

Two new quality standards, one for MDMA and another for psilocybine, have been published.

Information for manufacturers and sponsors regarding a new method for GMP inspections that will be used from 1 July 2024 and the extended validity of TGA issued GMP Certificates.

Some online health clinics are advertising and selling compounded medicines. However, it is important to know that compounded products are not identical to TGA approved products.

TGA officers executed a search warrant on a Sydney residence linked to an individual suspected of being involved in the manufacture and sale of compounded semaglutide.

The TGA and Health Canada have signed a Memorandum of Understanding to further increase collaboration and reliance on Good Manufacturing Practice inspections conducted in countries outside each other's borders.

From 3 June 2024, we will be using a new Good Manufacturing Practice (GMP) guide for medicines, active pharmaceutical ingredients and sunscreens.

Announcement about the launch of the pilot Single Inspection Program, a global approach to Good Manufacturing Practice inspections of third country manufacturers.

This instrument is made under Schedule 5A to the Therapeutic Goods Regulations 1990 and Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.

We've created a new GMP clearance Sponsor Information Dashboard (SID) to provide industry with current information about our processing times, workload and key messages. We have also updated our GMP clearance guidance.

Find out about how GMP clearances for manufacturing sites in Bulgaria can now be assessed via the Mutual Recognition Agreement (MRA) pathway.

Information about GMP clearances issued via the MRA Pathway that expire on 31 December 2023 as well as information on the ongoing use of the GMP clearance questionnaire.

The TGA has issued 5 infringement notices to Affinity Corp Australia Pty Ltd for the alleged unlawful advertising of medicinal cannabis products.

Delays in processing timeframes of applications to extend GMP Clearances.

We are conducting surveys to collect information about medical devices manufactured at the point-of-care.

Essential principle 7 now mentions nanomaterials explicitly (see EP 7.7)

Christopher Ramsey, the Director of AusLabs, Smart Labs and iSARMs, has been sentenced 2 years imprisonment and fined $300,000 for his role in the manufacture, supply and advertising of illegal Selective Androgen Receptor Modulators and nootropic products. Mr Ramsey’s three companies also received significant fines totalling $2,225,000.

More applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway.

The TGA has issued 12 infringement notices totalling $159,840 to a manufacturer of listed complementary medicines after a recent inspection of the company’s premises identified unacceptable manufacturing practices.

On 25 October 2022, Natural Franchises Pty Ltd pleaded guilty in a Sydney court to over 200 offences of the Therapeutic Goods Act 1989 for the manufacture, supply and advertising of unapproved therapeutic goods.

The TGA has issued 7 infringement notices totalling $93,240 to Cyclotek Queensland Pty Ltd

Update to the manufacturing principles for medicinal products

Conducting domestic inspections during the Coronavirus (COVID-19) pandemic

Guidance to assist sponsors when using the code tables for GMP Clearance applications

Information to assist overseas manufactures who may undergo a remote Good Manufacturing Practice inspection during the COVID-19 pandemic